- Medicines and Healthcare products Regulatory Agency
- 20 February 2017
- Therapeutic area:
- Cardiovascular disease and lipidology, GI, hepatology and pancreatic disorders, Radiology and imaging, and Urology and nephrology
Prescribing information has been updated to help to minimise the risk of serious adverse reactions in patients with cardiac disease.
Clarification to this article as of 3 April 2017
One of the 9 cases with a fatal outcome was incorrectly attributed to hyoscine butylbromide injection. We would like to clarify that we have received 8 reports of patients who died after receiving intravenous or intramuscular injection of hyoscine butylbromide. We will continue to closely monitor the safety of hyoscine butylbromide in the UK.
Advice for healthcare professionals:
- hyoscine butylbromide injection can cause serious adverse effects including tachycardia, hypotension, and anaphylaxis
- these adverse effects can result in a fatal outcome in patients with underlying cardiac disease, such as those with heart failure, coronary heart disease, cardiac arrhythmia, or hypertension
- hyoscine butylbromide injection should be used with caution in patients with cardiac disease
- monitor these patients, and ensure that resuscitation equipment, and personnel who are trained how to use this equipment, are readily available
- hyoscine butylbromide injection remains contraindicated in patients with tachycardia
Hyoscine butylbromide (Buscopan), given intravenously or intramuscularly, is indicated in acute muscular spasm, as in renal or biliary colic; in radiology for differential diagnosis of obstruction and to reduce spasm and pain in pyelography; and in other diagnostic procedures where spasm may be a problem (eg, gastroduodenal endoscopy).
Risk of adverse reactions
We have received 9 reports of patients who died after receiving hyoscine butylbromide injection (including a report from a coroner). In most of these cases, the fatal adverse reaction was reported as acute myocardial infarction or cardiac arrest.
Hyoscine butylbromide injection can cause adverse effects including tachycardia, hypotension, and anaphylaxis. These effects can be more serious in patients with underlying cardiac disease (eg, heart failure, coronary heart disease, cardiac arrhythmia, or hypertension). Several reports have noted that anaphylaxis is more likely to be fatal in patients with underlying coronary heart disease compared with those without.1 2
Reporting of suspected adverse reactions
Suspected adverse reactions should be reported to us on a Yellow Card.
Article citation: Drug Safety Update volume 10 issue 7, February 2017: 1.
Published: 20 February 2017